Measurement and automated peritoneal dialysis apparatus and methods

Abstract

A measuring device for a peritoneal dialysis apparatus (10) comprises a connection device (102) which is in contact with a shunt line system (104) of the peritoneal dialysis apparatus (10) and an electrochemical sensor device (110). The measuring device (100) receives spent dialysis fluid through the shunt line system (104) when the dialysis apparatus (10) is connected to a patient (12). The electrochemical sensor device (110) in contact with the spent dialysis fluid outputs an electrical signal in response to the content of urea and glucose of the spent dialysis fluid for data processing and / or data presentation of the electrical signal.

Description

Technical Field

[0001] This invention relates to a measuring device for a peritoneal dialysis device, an automated peritoneal dialysis device, and a measuring method for a peritoneal dialysis device. Background Technology

[0002] Patients with complete or partial loss of kidney function can be treated with renal replacement therapies such as hemodialysis and peritoneal dialysis. Hemodialysis is performed in a hospital, while peritoneal dialysis can be performed by the patient at home. In automated peritoneal dialysis, the peritoneum in the abdominal cavity is used to remove waste and water from the blood. Although automated peritoneal dialysis is known to be quite effective, current knowledge is insufficient to determine the actual effectiveness of peritoneal dialysis.

[0003] Therefore, improvements in peritoneal dialysis are welcome. Summary of the Invention

[0004] The present invention aims to provide an improvement in measurement.

[0005] This invention is defined by the independent claims. The dependent claims define the embodiments. Attached Figure Description

[0006] The following describes exemplary embodiments of the present invention by way of example only, with reference to the accompanying drawings, wherein...

[0007] Figure 1 An example of an automated peritoneal dialysis device is illustrated.

[0008] Figure 2 The illustration shows an example of measuring the waste dialysate and its flow rate in the drainage line;

[0009] Figure 3 An example of a peritoneal dialysis cycle is illustrated;

[0010] Figure 4 An example of a measuring device with a bypass line is illustrated;

[0011] Figure 5 An example of a data processing unit is illustrated; and

[0012] Figure 6 An example of a flowchart illustrating peritoneal dialysis measurement methods is shown. Detailed Implementation

[0013] The following embodiments are merely examples. While the specification may refer to "an" embodiment in multiple places, this does not necessarily mean that each such reference pertains to the same multiple embodiments, or that a feature applies only to a single embodiment. Individual features of different embodiments can also be combined to provide other embodiments. Furthermore, the terms "comprising" and "including" should be understood to mean that the described embodiments are not limited to consisting only of those features already mentioned, and such embodiments may also include features / structures not specifically mentioned. All combinations of embodiments are considered possible if they do not lead to structural or logical contradictions.

[0014] It should be noted that while the figures illustrate various embodiments, they are simplified diagrams showing only some structural and / or functional entities. Connections shown in the figures can refer to logical or physical connections. It will be apparent to those skilled in the art that the apparatus may also include functions and structures other than those described in the figures and text. It should be understood that details of some functions, structures, and signals used for measurement and / or control are irrelevant to the actual invention. Therefore, they need not be discussed in more detail here.

[0015] Currently, the problem with peritoneal dialysis is that the effectiveness of the treatment, such as how the peritoneum works, can only be measured manually, where the patient provides four bags daily as samples from the drainage bag. The patient must record when drainage and administration begin, the weight of the bag, and the type of solution used. The patient brings the collected samples and records to the hospital, where nurses process and submit the samples for further analysis. The nurses must then copy the results to the hospital's computer, which calculates the patient's peritoneal characteristics. Nurses also simulate various machine-based therapy models based on the obtained results. This method is extremely laborious, error-prone, and complex for the patient, especially if he or she typically uses a dialysis machine for nighttime treatment. Currently, all of this takes approximately two business days, and patients may receive results one to two months after completing their portion.

[0016] Figure 1 An example of an automated peritoneal dialysis device 10 is illustrated, including a measuring device 100. The automated peritoneal dialysis device 10 also includes or is connected to a peritoneal solution reservoir 11, which contains at least one solution. However, the measuring device 100 is not necessarily part of the automated peritoneal dialysis device 10, and may be a separate device that can be connected to the automated peritoneal dialysis device 10.

[0017] For example, peritoneal dialysis can be performed overnight while patient 12 is sleeping in bed 124 at his / her home. The measuring device may be disposable. The measuring device 100 for peritoneal dialysis device 10 includes a connector 102, which can be connected to the drainage tubing system 104 of the peritoneal dialysis device 10, at least when the peritoneal dialysis device 10 is used for peritoneal dialysis. The connector 102 may be a tube connector. The tube connector may have threads, and its attachment may be based on a suitable shape for a tight connection, and / or based on friction. The measuring device 100 also includes at least one electrochemical sensor 110, which includes a tube having at least one chemical sensor element. In addition, the measuring device 100 includes a data processing unit 106 and a user interface 108, or is connected to the data processing unit 106 and the user interface 108.

[0018] Those skilled in the art are familiar with the operation of at least one electrochemical sensor 110. For example, the operation of at least one electrochemical sensor 110 may be based on enzyme catalysis. At least one electrochemical sensor 110 and its connector 102 are optional, i.e., they are used only for a single dialysis. At least one electrochemical sensor 110 can operate continuously for several hours and can be based on potential detection.

[0019] At least one electrochemical biosensor measures the urea concentration in waste dialysate. The measurement technique of the urea biosensor can be based on 1) enzymatic hydrolysis of urea (CHNO) molecules by immobilized urease activated via an enzyme activation solution, and / or 2) ion-selective electrochemical measurement based on potential detection to generate ammonium (NH4+) ions. To improve the NH4+ ion selectivity of the biosensor, the sensor can be treated with an ammonium ion carrier.

[0020] To avoid interference from Na+ ions in the detection of NH4+, differential electrochemical measurement is used: the correction of electrochemical background is accomplished by measuring the potential difference between two points (with and without urease).

[0021] When the dialysis device 10 is connected to the patient 12 using the patient tubing 122, the measuring device 100 receives waste dialysis fluid through the drainage tubing system 104 of the peritoneal dialysis device 10.

[0022] At least one electrochemical sensor 110 in contact with the waste dialysate stream continuously outputs at least one electrical signal in response to the content of urea and glucose in the waste dialysate. The signal parameters carry information about the urea and glucose content.

[0023] In one embodiment, at least one electrochemical sensor 110 may be based on a porous silk fibroin membrane having immobilized urease within a polydimethylsiloxane shell. In another embodiment, at least one electrochemical sensor 110 may be based on the electropolymerization of 3,4-ethylenedioxythiophene monomer on a hierarchical network of carbon nanotubes and gold nanotubes. In yet another embodiment, at least one electrochemical sensor 110 may be based on a metalloenzyme (urease or uricase), which may be synthetic or natural. In yet another embodiment, at least one electrochemical sensor 110 may be based on enzyme-free electrochemical detection.

[0024] In embodiments, at least one electrochemical sensor 110 may detect glucose based on amperometric sensing, wherein glucose is oxidized, resulting in the generation of hydrogen peroxide, and the hydrogen peroxide is ultimately detected by the electrode of at least one electrochemical sensor 110. These are merely examples of possibilities for at least one electrochemical sensor 110, and are not limited thereto. Those skilled in the art are familiar with electrochemical sensors.

[0025] The data processing unit 106 processes at least one electrical signal accordingly and forms the urea percentage and glucose percentage of the waste dialysis fluid based on the at least one electrical signal in a continuous manner.

[0026] Any detector, such as at least one electrochemical sensor 110, integrates its inputs over a period of time to form its output. Despite this characteristic, the measurement may be considered continuous. Furthermore, even if the measuring device 100 is digital and it outputs discrete values ​​sequentially, the measurement is considered continuous.

[0027] In one embodiment, the user interface 108 may then display the urea percentage and glucose percentage. In another embodiment, the user interface 108 includes a screen, keyboard, and / or touchscreen. In yet another embodiment, the user interface 108 may include a speaker. In yet another embodiment, the user interface 108 may display the urea percentage and glucose percentage in a continuous manner. In yet another embodiment, the user interface 108 may display the urea percentage and glucose percentage in a continuous manner after a delay. The delay may be as long as the duration of dialysis. In this way, if peritoneal dialysis is performed the night before the morning, the urea percentage and glucose percentage may be displayed in the morning. Therefore, the measuring device 100 may include a connector 102 and at least one electrochemical sensor 110 (see [link to device 100]). Figure 1The vertical dashed line between the data processing unit 106 and one or more sensors 110 indicates that the measuring device 100 may include a connector 102, at least one chemical sensor 110, and the data processing unit 106. The data processing unit 106 may further include or be connected to a user interface 108. In various embodiments, the measuring device 100 may include additional components and / or devices.

[0028] Note that in the embodiments, the data processing unit 106 may be directly connected to the measuring device 100, or the measuring device 100 may include a transmitter 130 that is directly connected to at least one electrochemical sensor 110 (see the curve and dashed line between them), and the measuring device 100 is connected to an external computer 202 via the transmitter 130, which may include the data processing unit 106 for processing data.

[0029] In one embodiment, the measuring device 100 may include a flow meter 112 that can transmit flow data (measuring the total volume of drained waste dialysate) received by the measuring device 100 during the drainage phase to a data processing unit 106. The data processing unit 106 can detect the sequence of different flow rates in the dialysis cycle and correlate the urea percentage and glucose percentage with the sequence of different flow rates. In one embodiment, at least one drainage phase can be measured individually. In another embodiment, at least two drainage phases can be measured individually. In yet another embodiment, each drainage phase of multiple dialysis cycles can be measured individually.

[0030] Figure 3 An example of a peritoneal dialysis cycle is illustrated. The vertical axis represents volume V at any scale, and the horizontal axis represents time T at any scale. Continuous cyclic peritoneal dialysis is a method of peritoneal dialysis using an automated peritoneal dialysis device 10, which can, for example, perform 1 to 5 dialysate exchanges per night.

[0031] The peritoneal dialysis procedure consists of three phases: filling, holding, and drainage. During the filling phase, dialysis fluid is administered into the peritoneal cavity of patient 12 through patient tube 112.

[0032] During the predetermined residence period, waste and fluid diffuse through the peritoneum into the dialysate.

[0033] At the end of the retention phase, the waste dialysate is removed from the peritoneal cavity of patient 12 through drainage tubing system 104. These phases may be repeated multiple times throughout the night.

[0034] A cycle 1 of peritoneal dialysis treatment includes a filling phase 3, during which peritoneal dialysis solution is injected into the peritoneal cavity of the patient 12; a residence phase 4, during which dialysis fluid is collected from the peritoneum to collect waste and fluid; and an excretion phase 5, during which waste dialysis fluid containing waste and fluid is removed from the peritoneal cavity. A first drainage phase 2 may be performed before any of the filling, residence, and drainage phases. The first drainage phase 2 (also labeled 5) is similar to drainage phase 5 following residence phase 4, except that there is no filling phase 3 preceding it. A final filling phase 6 may be performed after the last cycle. The final filling phase 6 (also labeled 3) is similar to filling phase 3 following drainage phase 5, except that there is no immediately performed peritoneal dialysis phase following it. Permissible residual volume is labeled with the number 7, and the maximum permissible filling volume is labeled with the number 8.

[0035] In one embodiment, the data processing unit 106 can process at least one signal from at least one drainage phase of a dialysis cycle. In another embodiment, the data processing unit 106 can process at least one signal from at least two drainage phases of a dialysis cycle. In yet another embodiment, the data processing unit 106 can process at least one signal from each drainage phase of a dialysis cycle. In this way, detailed information about peritoneal dialysis can be obtained, which can be used to determine the actual efficiency of peritoneal dialysis. Furthermore, it is possible to obtain information about continuous drainage phases, which can be used to improve the efficiency and quality of peritoneal dialysis.

[0036] In one embodiment, at least one electrochemical sensor 110 may additionally and continuously output at least one electrical signal in response to the content of at least one of the following in the waste dialysate: protein, creatinine, at least one electrolyte, and phosphate. The data processing device 106 may then form a percentage of these components in the waste dialysate based on the at least one electrical signal. For example, creatinine indicates kidney health. Creatinine is derived from the biological processes of creatine, phosphocreatine, and adenosine triphosphate.

[0037] exist Figure 4 In an example of the embodiment illustrated in the figure, the measuring device 100 may include a bypass line 114, which in turn includes at least one electrochemical sensor 110. The bypass line 114 may receive a portion of the waste dialysate from the drainage tubing system 104 of the peritoneal dialysis device 10. Therefore, at least one electrochemical sensor 110 may be in contact with the waste dialysate of the bypass line 114.

[0038] exist Figure 1 , 2In the embodiment illustrated in Figure 4, connector 102 may contact at least one of the following: drainage connector 104' and drainage tubing 104" of the peritoneal dialysis device 10. That is, connector 102 may be connected to drainage connector 104', and in this way it is adjacent to the peritoneal dialysis device 10. Alternatively, connector 102 may be connected to drainage tubing 104", and in this way it may be located at a desired position further away from the peritoneal dialysis device 10 along drainage tubing 104".

[0039] When waste dialysis fluid is received through patient tubing 122, drainage connector 104' and drainage tubing 104" can guide the waste dialysis fluid from patient 12 to waste fluid device 116.

[0040] exist Figure 2 In the illustrated embodiment, the measuring device 100 may include a filter 118 that separates at least one of the following before it comes into contact with at least one electrochemical sensor 110 along the flow direction of the waste dialysate: fibrin and blood cells. In this way, fibrin and blood cells do not come into contact with at least one electrochemical sensor 110, and they do not interfere with the measurement. Filtration is a physical operation that separates solid matter and fluid from a mixture using a porous filter medium with a complex structure through which fluid can pass.

[0041] exist Figure 1 In the illustrated embodiment, the measuring device 100 can perform calibration in response to contact between a predetermined liquid and at least one electrochemical sensor 100. During calibration, the predetermined liquid flows through the drainage system 104, and the data processing unit 106 sets a predetermined value for the analyte based on at least one electrical signal from the at least one electrochemical sensor 100. The predetermined liquid may be derived from a library 11 of solutions. Calibration can be considered as baseline correction. In one embodiment, the predetermined liquid may include known percentages of urea and glucose, and the data processing unit 106 is configured to display values ​​corresponding to those percentages. In another embodiment, the predetermined liquid may also include known percentages of protein, creatinine, at least one electrolyte, and phosphate, and the data processing unit 106 may be configured to display values ​​corresponding to those percentages. Standard solutions are typically used as the predetermined liquid. For example, the predetermined liquid may be clean dialysate, i.e., unused dialysate.

[0042] In one embodiment, the measuring device 100 can be calibrated during each dialysis cycle, including a residence phase during which a predetermined fluid is delivered to the drainage line system 104.

[0043] exist Figure 1In the illustrated embodiment, the measuring device 100 may include a clock 120. The clock 120 may be included in or connected to the data processing unit 106. The measuring device 100 may also include a flow meter 112, which transmits data received by the measuring device 100 regarding the flow rate of the waste dialysate to the data processing unit 106. The data processing unit 106 can then time-stamp different flow rates of the dialysis cycle based on the time signal of the clock 120, and correlate the urea percentage and glucose percentage with the time stamps. Correspondingly, the data processing unit 106 can time-stamp the percentages of protein and creatinine. In this way, detailed information about changes over time can be collected from the waste dialysate. Information about a particular stage can be used for the next stage of peritoneal dialysis. For example, this information can also be used by a neurologist.

[0044] In this implementation, the data processing unit 106 can generate peritoneal balance test (PET) values ​​and / or peritoneal function test (PFT) values. These values ​​reflect the condition of the peritoneal cavity in patient 12.

[0045] In this implementation, the amount or concentration of dialysate may vary based on information. In this implementation, the time intervals between dialysis stages may vary based on information.

[0046] In this implementation, the number of dialysis stages can vary based on the information provided.

[0047] In this implementation, the time interval between dialysis sessions can vary based on information.

[0048] In this implementation, if the measured value deviates from a medically acceptable range, a warning may be presented to the patient 12. Medically acceptable values ​​are those defined in medical textbooks. Those skilled in the art and medical personnel such as physicians are familiar with acceptable and unacceptable values. Unacceptable values ​​may refer to, for example, a failure of normal dialysis procedures, peritoneal cavity failure, or disease.

[0049] In this implementation, an alarm will be triggered if the measured value deviates from a medically acceptable range. The alarm may be directed to patient 12, patient 12's close relatives, caregivers, and / or medical personnel. The alarm may be presented to patient 12 in the form of sound and / or light. The alarm may also be sent to patient 12's close relatives, caregivers, and / or medical personnel via telephone message. The telephone message may be sound, text, and / or graphic presentation on a mobile phone or computer screen.

[0050] In an embodiment, the data processing unit 106 may include one or more processors 500 and one or more memories 502. The one or more memories 502 may include computer program code capable of processing at least one signal and information carried by said at least one signal. With one or more processors 500, the one or more memories 502 and the computer program code may enable the measuring device 100 to determine at least the urea percentage and glucose percentage of the waste dialysate based on at least one electrical signal. The percentage of any other substance in the waste dialysate may also be determined accordingly. The data processing unit 106 may also control the peritoneal dialysis apparatus 10 in an automatic manner.

[0051] In conclusion, this can be interpreted as follows: when patient 12 connects himself / herself to the automated peritoneal dialysis device 10, he / she also connects himself / herself to the measuring device 100. The measuring device 100 automatically and continuously measures and stores the desired substances in the waste dialysate. In such a way... Figure 1 In the illustrated embodiment, the measuring device 100 may include a transmitter 130 that can transmit the results of the measurement in progress to a clinic, hospital, or similar location, either wired or wirelessly. Figure 1 An external computer 202 is used, where one or more experts can analyze the results. For example, patient 12 may have a blood test done monthly in a laboratory, and the blood test analysis can be performed based on the results of peritoneal dialysis. The computer in a laboratory, clinic, hospital, data processing unit 106, or any medical facility with appropriate computers, along with the blood test analysis and peritoneal dialysis results, can calculate the peritoneal condition of patient 12. For example, the condition could be permeability.

[0052] As more peritoneal circulation and blood tests are performed, self-learning neural networks or artificial intelligence can be used to address and predict significant medical changes in peritoneal function in patient 12. Data processing unit 106, computer of the medical facility ( Figure 1 The external computer (and / or cloud server 200) may include a self-learning neural network or artificial intelligence. Regardless of the presence or absence of a self-learning neural network / artificial intelligence, peritoneal dialysis can be initiated with a lower volume and lower glucose content because the measuring device 100 can quickly detect dialysis insufficiency and more effectively modify the peritoneal dialysis to use a larger volume and / or higher glucose content. These changes can be introduced immediately after a single peritoneal dialysis treatment so that the next peritoneal dialysis session uses the modified volume and / or content. Such changes can even be introduced on a per-peritoneal-cycle basis. All of these features have a positive effect on the health of the patient 12.

[0053] Table 1 below illustrates examples of measurement ranges for clinical analytes in waste dialysate that the measuring device may be used for.

[0054] Table 1. Measurement range of clinical analytes in waste dialysis fluid

[0055] Components concentration Anhydrous glucose 0–240 mmol / L Urea 0–100 mmol / L Creatinine 0–1000 μmol / L Total protein 0–10 g / L phosphate 0–5 mmol / L

[0056] Figure 6 This is a flowchart of the measurement method. In step 600, when the dialysis apparatus 10 is connected to the patient 12 using the patient tubing 122, the measuring device 100 receives waste dialysate through the drainage tubing system 104 of the peritoneal dialysis apparatus 10. In step 602, in response to the urea and glucose content in the waste dialysate, at least one electrical signal is continuously output by at least one electrochemical sensor 110 in contact with the waste dialysate flow. In step 604, the data processing unit 106 continuously processes the at least one electrical signal. In step 606, the data processing unit 106 continuously forms the urea percentage and glucose percentage of the waste dialysate based on the at least one electrical signal. In step 608, the urea percentage and glucose percentage are presented by the user interface 108.

[0057] Figure 6 The method shown can be implemented as a logic circuit scheme or a computer program (see [reference]). Figure 5 The computer program can be placed on a computer program distribution device for distribution. The computer program distribution device can be read by the data processing unit 106 or some other suitable computer, and it encodes computer program commands, performs measurements, and optionally controls the automated peritoneal dialysis device 10 based on the measurement results.

[0058] Computer programs can be distributed using a distribution medium, which can be any medium readable by the controller. The medium can be a program storage medium, memory, a software distribution package, or a compressed software package. In some cases, at least one of the following can be used for distribution: near-field communication signals, short-range signals, and long-range communication signals.

[0059] It will be apparent to those skilled in the art that the concept of this invention can be implemented in various ways as technology advances. The invention and its embodiments are not limited to the above-described examples and embodiments, but can be varied within the scope of the claims.

Claims

1. A measuring device for a peritoneal dialysis apparatus, wherein, The measuring device includes A connection device is configured to contact the shunt tubing system of the peritoneal dialysis device; At least one electrochemical sensor device; A clock provides a time signal; Data processing equipment; User interface devices are used for data presentation; and The measuring device is configured to receive a predetermined fluid for calibration during each dialysis cycle, as well as waste dialysate through the shunt system of the peritoneal dialysis device, the dialysis cycle including a residence phase during which the predetermined fluid is delivered to the shunt system, and the waste dialysate being received when the dialysis device is connected to a patient; The at least one electrochemical sensor device, configured to contact a predetermined liquid for calibration and the waste dialysate, is configured to continuously output at least one electrical signal in response to the urea and glucose content of the predetermined liquid for calibration and the waste dialysate, for data processing and / or data presentation of the at least one electrical signal; and The data processing device is configured as follows: Receive data regarding the flow rate of the waste dialysate; Continuously process the at least one electrical signal, The percentage of urea and the percentage of glucose in the waste dialysate are determined based on the at least one electrical signal. The different flow rates of the dialysis cycle are time-stamped based on the time signal from the clock. Associate the urea percentage and the glucose percentage with the time marker; and The user interface is configured to present the urea percentage and glucose percentage associated with the time marker.

2. The measuring device according to claim 1, wherein, The measuring device includes a flow meter configured to transmit waste dialysis fluid flow data received by the measuring device to the data processing and / or the data presentation for detecting the sequence of different flow rates in the dialysis cycle, and to correlate the data processing and / or the data presentation of urea percentage and glucose percentage with the sequence of the different flow rates.

3. The measuring device according to claim 2, wherein, The at least one electrochemical sensor device is configured to output the at least one electrical signal for data processing of the at least one signal for each of the dialysis cycles.

4. The measuring device according to claim 1, wherein, The at least one electrochemical sensor device is additionally configured to continuously output at least one electrical signal in response to the content of at least one of the following in the waste dialysate: protein, creatinine, at least one electrolyte, and phosphate, for the purpose of forming the percentage of them included in the waste dialysate based on the at least one electrical signal.

5. The measuring device according to claim 1, wherein, The measuring device includes a bypass line that includes the at least one electrochemical sensor device and is configured to receive a portion of the waste dialysate from the shunt system of the peritoneal dialysis apparatus; and the at least one electrochemical sensor device is configured to contact the waste dialysate in the bypass line.

6. The measuring device according to claim 1, wherein, The connection device is configured to contact at least one of the following: a shunt connector and a shunt line of the peritoneal dialysis device, the shunt connector and the shunt line being configured to direct the patient's waste dialysate to a waste fluid device.

7. The measuring device according to claim 1, wherein, The measuring device includes a filtration device configured to separate at least one of the following before contact with the at least one electrochemical sensor device: fibrin and blood cells.

8. The measuring device according to claim 1, wherein, The data processing device is configured to detect the sequence of different flow rates in the dialysis cycle and correlate the urea percentage and the glucose percentage with the sequence of the different flow rates.

9. An automated peritoneal dialysis device, wherein, The automated peritoneal dialysis device includes the measuring device as described in claim 1.

10. The automated peritoneal dialysis apparatus of claim 9, wherein the measuring device includes a flow meter configured to transmit data received by the measuring device regarding the flow rate of the waste dialysis fluid to the data processing device.

Images